Therapy of patients with human T-cell lymphotrophic virus I-induced adult T-cell leukemia with anti-Tac, a monoclonal antibody to the receptor for interleukin-2.
T A Waldmann, C K Goldman, K F Bongiovanni...
https://pubmed.ncbi.nlm.nih.gov/2846094Completed
Phase 1
All Genders
ID00001249
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
Led by National Cancer Institute (NCI) · Updated on 2008-03-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
The study purpose is to evaluate the clinical response to multidose administration of anti-Tac monoclonal antibody conjugated with 10 mCi 90Y in patients with Tac-expressing adult T-cell leukemia (ATL).
CONDITIONS
Official Title
Treatment of Tac-Expressing Cutaneous T-Cell Lymphoma (CTCL) and Adult T-Cell Leukemia (ATL) With Yttrium-90 Radiolabeled Anti-Tac
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
DISEASE CHARACTERISTICS:
Histologically confirmed adult T-cell leukemia/lymphoma (ATL) or cutaneous T-cell lymphoma (CTCL).
Reactivity of at least 10% of peripheral blood, lymph node, or dermal malignant cells with anti-Tac as determined by immunofluorescent staining or soluble IL-2 receptor level greater than 1,500 U required.
All stages of Tac-expressing T-cell leukemia and lymphoma eligible except Stage I CTCL.
All forms of ATL eligible, including the "smoldering" type as well as aggressive disease.
No symptomatic CNS disease other than tropical spastic paraparesis.
Asymptomatic CNS disease with demonstrable malignant cells in the CSF allowed (such patients receive CNS therapy, e.g., intrathecal methotrexate and/or CNS irradiation, as appropriate).
PRIOR/CONCURRENT THERAPY:
Biologic Therapy: Not specified.
Chemotherapy:
CTCL must have failed initial chemotherapy.
ATL may or may not have had prior chemotherapy.
At least 4 weeks since prior cytotoxic chemotherapy.
Endocrine Therapy: Not specified.
Radiotherapy: At least 4 weeks since prior radiotherapy.
Surgery: Not specified.
PATIENT CHARACTERISTICS:
Age: 18 and over.
Performance status: Not specified.
Life expectancy: Greater than 1 month.
Hematopoietic: WBC at least 3,000, Platelets at least 75,000.
Hepatic: Not specified.
Renal: Not specified.
Other:
No pregnant women.
Negative pregnancy test required of fertile women.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Cancer Institute (NCI)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Nature of the bifunctional chelating agent used for radioimmunotherapy with yttrium-90 monoclonal antibodies: critical factors in determining in vivo survival and organ toxicity.
R W Kozak, A Raubitschek, S Mirzadeh...
https://pubmed.ncbi.nlm.nih.gov/2785435